Medication Record

  1. StudyEvent: ODM
    1. Medication Record
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Descripción

Country No.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Centre No.
Descripción

Centre No.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject No.
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
None
Descripción

If no concomitant medication, skip the rest of the form.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0549184
Concomitant Medication Record
Descripción

Concomitant Medication Record

Alias
UMLS CUI-1
C2347852
Drug Name
Descripción

Drug Name

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose/Units
Descripción

Concomitant Agent Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2826638
Route
Descripción

Concomitant Medication Route

Tipo de datos

text

Alias
UMLS CUI [1]
C2826730
Prior
Descripción

Prior Medication- Recording is limited to treatment with anti-platelet agents, anticoagulant agents, fibrinolytics starting within 1 week prior to first dose.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C2826667
UMLS CUI [1,3]
C2963157
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C2826667
UMLS CUI [2,3]
C0003280
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C2826667
UMLS CUI [3,3]
C0016018
After
Descripción

Follow-up Medication- Recording limited to treatment with anti-platelet-agents, anti-coagulant-agents, fibrinolytics and medication given as corrective treatment foradverse events, starting with the day after the last dose of study drug or the day of venography, whichever occurs last, to the end of the follow-up period.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C2963157
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2347804
UMLS CUI [2,4]
C0003280
UMLS CUI [3,1]
C2347852
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C2347804
UMLS CUI [3,4]
C0016018
UMLS CUI [4,1]
C2347852
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C2347804
UMLS CUI [4,4]
C0392360
UMLS CUI [4,5]
C0877248
Duration Dates: Start
Descripción

Concomitant Medication Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Duration Dates: End
Descripción

Concomitant Medication Stop Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing at the end of the study
Descripción

Ongoing Concomitant Medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
Indication
Descripción

Concomitant Medication Indication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
AE form number
Descripción

AE form number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0600091

Similar models

Medication Record

  1. StudyEvent: ODM
    1. Medication Record
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
No Concomitant Medication
Item
None
boolean
C2347852 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Item Group
Concomitant Medication Record
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Concomitant Agent Total Daily Dose
Item
Total Daily Dose/Units
text
C2826638 (UMLS CUI [1])
Concomitant Medication Route
Item
Route
text
C2826730 (UMLS CUI [1])
Recent prior concomitant medication (Anti-platelet agents, anticoagulants, fibrinolytics)
Item
Prior
boolean
C0332185 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
C2963157 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C2826667 (UMLS CUI [2,2])
C0003280 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C2826667 (UMLS CUI [3,2])
C0016018 (UMLS CUI [3,3])
Concomitant medication (anti-platelet agents, anti-coagulants, fibrinolytics or drugs for AEs) taken after study
Item
After
boolean
C2347852 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C2963157 (UMLS CUI [1,4])
C2347852 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C0003280 (UMLS CUI [2,4])
C2347852 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C2347804 (UMLS CUI [3,3])
C0016018 (UMLS CUI [3,4])
C2347852 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C2347804 (UMLS CUI [4,3])
C0392360 (UMLS CUI [4,4])
C0877248 (UMLS CUI [4,5])
Concomitant Medication Start Date
Item
Duration Dates: Start
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Stop Date
Item
Duration Dates: End
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing Concomitant Medication
Item
Ongoing at the end of the study
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication Indication
Item
Indication
text
C2826696 (UMLS CUI [1])
AE form number
Item
AE form number
integer
C0877248 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])